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The benefit of EXtending oral antiCOAgulation treatment EXCOA after acute cerebral vein thrombosis CVT : EXCOA-CVT cluster randomized trial protocol

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dc.contributor.authorMiranda, Bruno
dc.contributor.authorAaron, Sanjith
dc.contributor.authorArauz, Antonio
dc.contributor.authorBarinagarrementeria, Fernando
dc.contributor.authorBorhani-Haghighi, Afshin
dc.contributor.authorCarvalho, Marta
dc.contributor.authorConforto, Adriana B.
dc.contributor.authorCoutinho, Jonathan M.
dc.contributor.authorStam, Jan
dc.contributor.authorCanhão, Patrícia
dc.contributor.authorFerro, José
dc.date.accessioned2021-06-04T11:12:16Z
dc.date.available2021-06-04T11:12:16Z
dc.date.issued2018
dc.descriptionCopyright © 2018 World Stroke Organizationpt_PT
dc.description.abstractRationale: After a cerebral vein thrombosis, there is an increased risk of further venous thromboembolic events. The optimal duration of anticoagulation after cerebral vein thrombosis is unknown. Aim: To compare efficacy and safety of a policy of short- (3–6 months) versus long-term (12 months) anticoagulation (any type venous thromboembolic events) after cerebral vein thrombosis for the prevention of venous thromboembolic events. Sample size estimates: A sample of 1428 patients (749 per arm) allows detecting a reduction from 10 to 5% in the risk of venous thromboembolic event recurrence with 80% power at 5% significance, with 3% dropout rate. Methods and design: An international multicenter, prospective cluster-randomized trial with equal allocation between both interventions (ISRCTN25644448). Each cluster is a participating center, which accepted to be randomly allocated to one of the anticoagulation policies. Eligible patients are adults with radiologically confirmed cerebral vein thrombosis within 30 days, and stable to initiate post-acute anticoagulation. Patients judged by the investigator to be an absolute indication for permanent anticoagulation are excluded. Follow-up is at 6, 12 and 24 months. Study outcomes: Primary efficacy outcome is any symptomatic and confirmed fatal/nonfatal venous thromboembolic event (recurrent-cerebral vein thrombosis or non-cerebral venous thromboembolic event). Primary safety outcomes include bleeding events during treatment periods and death from any cause. Discussion: This study responds to a knowledge gap in the post-acute management of cerebral vein thrombosis patients by comparing short- versus long-term anticoagulation for the prevention of venous thromboembolic event recurrence.pt_PT
dc.description.versioninfo:eu-repo/semantics/publishedVersionpt_PT
dc.identifier.citationInt J Stroke. 2018 Oct;13(7):771-774pt_PT
dc.identifier.doi10.1177/1747493018778137pt_PT
dc.identifier.eissn1747-4949
dc.identifier.issn1747-4930
dc.identifier.urihttp://hdl.handle.net/10451/48324
dc.language.isoengpt_PT
dc.peerreviewedyespt_PT
dc.publisherSAGEpt_PT
dc.relation.publisherversionhttps://journals.sagepub.com/home/wsopt_PT
dc.subjectCerebral vein and dural sinus thrombosispt_PT
dc.subjectAnticoagulationpt_PT
dc.subjectCluster-randomized trialpt_PT
dc.subjectVenous thromboembolismpt_PT
dc.titleThe benefit of EXtending oral antiCOAgulation treatment EXCOA after acute cerebral vein thrombosis CVT : EXCOA-CVT cluster randomized trial protocolpt_PT
dc.typejournal article
dspace.entity.typePublication
oaire.citation.endPage774pt_PT
oaire.citation.issue7pt_PT
oaire.citation.startPage771pt_PT
oaire.citation.titleInternational Journal of Strokept_PT
oaire.citation.volume13pt_PT
person.familyNameAndré e Silva Miranda
person.familyNameCanhão
person.familyNameMorão Cabral Ferro
person.givenNameBruno
person.givenNamePatrícia
person.givenNameJosé Manuel
person.identifier.ciencia-id061D-9631-86C9
person.identifier.ciencia-id8F12-6A40-BE2E
person.identifier.ciencia-id6F16-7E25-7AAF
person.identifier.orcid0000-0003-4660-6051
person.identifier.orcid0000-0003-3816-0416
person.identifier.orcid0000-0002-2343-9097
person.identifier.scopus-author-id6603685711
rcaap.rightsrestrictedAccesspt_PT
rcaap.typearticlept_PT
relation.isAuthorOfPublicationdaeb1942-0de6-4300-b4d8-029f3e312a82
relation.isAuthorOfPublicatione9d5a53f-d0d3-4cc4-9807-879ef76be505
relation.isAuthorOfPublication9a568ce6-d218-44fc-982c-0ffe7bffc197
relation.isAuthorOfPublication.latestForDiscoverydaeb1942-0de6-4300-b4d8-029f3e312a82

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